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Clotting Tetrachoric Combined Testing Kit (Coagulation Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0030-07Model CA (PT+APTT) ：15 tests/kitRef NX-0030-11Model CA (PT+APTT+FIB)：15 tests/kitRef NX-0030-10Model CA (PT+APTT+ FIB) Specification 2: 10 tests/kitRef NX-0030-12Model CA (PT+APTT+ FIB) Specification 4: 30 tests/kitRef NX-0030-08Model CA (PT+APTT) Specification 4: 30 tests/kitRef NX-0030-09Model CA (PT+APTT+FIB) Specification 1: 1 test/kit
Identity
- Trade Name
- Clotting Tetrachoric Combined Testing Kit (Coagulation Method) EUDAMED
- Device Name
- Clotting Tetrachoric Combined Testing Kit (Coagulation Method) EUDAMED
- Model / Reference
- CA (PT+APTT) ：15 tests/kit EUDAMEDNX-0030-07 EUDAMEDCA (PT+APTT+FIB)：15 tests/kit EUDAMEDNX-0030-11 EUDAMEDCA (PT+APTT+ FIB) Specification 2: 10 tests/kit EUDAMEDNX-0030-10 EUDAMEDCA (PT+APTT+ FIB) Specification 4: 30 tests/kit EUDAMEDNX-0030-12 EUDAMEDCA (PT+APTT) Specification 4: 30 tests/kit EUDAMEDNX-0030-08 EUDAMEDCA (PT+APTT+FIB) Specification 1: 1 test/kit EUDAMEDNX-0030-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451728 EUDAMED06976117451766 EUDAMED06976117451759 EUDAMED06976117451773 EUDAMED06976117451735 EUDAMED06976117451742 EUDAMED
- Basic UDI-DI
- B-06976117451728 EUDAMEDB-06976117451766 EUDAMEDB-06976117451759 EUDAMEDB-06976117451773 EUDAMEDB-06976117451735 EUDAMEDB-06976117451742 EUDAMED
- EMDN Code
- W0103020199 GENERAL COAGULATION TESTS - OTHER EUDAMEDW01030299 HAEMOSTASIS REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Clotting Tetrachoric Combined Testing Kit (Coagulation Method) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976117451728 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (6)
- EUDAMED 51b97d8b-dd0a-4f47-b395-629f203f58f9 61 fields · synced Oct 5, 2026
- EUDAMED 7b538f96-cc9e-4101-a284-940ff745d147 61 fields · synced May 18, 2026
- EUDAMED c40ece0b-f701-43ba-8dfa-ffb9711f9f42 61 fields · synced Jul 10, 2026
- EUDAMED a6c372da-f138-49a2-b1af-c1832cdc781d 61 fields · synced Jul 12, 2026
- EUDAMED 9d02b5d1-4dd7-4cae-81b3-6c47395c568b 61 fields · synced Jul 17, 2026
- EUDAMED 2ceea3f4-f264-407c-ba04-b291608a111a 61 fields · synced Sep 17, 2026